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Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

About

Brief Summary

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
60 Years

Inclusion Criteria:

  • Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification
  • Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood
  • Age ≥ 18 years and ≤ 60 years
  • Adequate hepatic function within 48 hours prior to induction chemotherapy
  • Adequate renal functions within 48 hours prior to induction chemotherapy
  • ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3
  • Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified

Exclusion Criteria:

  • Acute promyelocytic leukemia (APL)
  • Known clinically active central nervous system (CNS) leukemia
  • Severe liver disease
  • Active infections
  • Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Known infection with human immunodeficiency virus (HIV)
  • Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)

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Study Stats
Protocol No.
19-001640
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03258931
For detailed technical eligibility, visit ClinicalTrials.gov.